Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study

Not Applicable

• Conditions: Faecal Incontinence
• Interventions: Procedure: Sacral neuromodulation in conventional implantation technique

• Registration Number: NCT04726904
• Lead Sponsor: Medical University of Vienna

Brief Summary

Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.

In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.

Detailed Description

Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used.

However, to date no studies exist comparing different surgical techniques. The present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "H" technique and the commonly conducted non radiological lead implantation using anatomical landmarks.

In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens.Afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted.

The results will be compared to the preliminary study of Mueller et al., where they used the new fluoroscopy guided "H" technique in five cadavers.

Study Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-23
• Study First Posted: 2021-01-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-01
• Last Update Posted: 2021-08-03
• Primary Completion: 2021-08-15
• Study Completion: 2021-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Cadaver study
• All of these individuals had donated their bodies to medical education and research in form of an informed consent.

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional lead placement	Sacral neuromodulation in conventional implantation technique	The cadaver is placed in the prone position. The exact location for insertion of the needle is defined with the conventional technique.

Primary Outcome Measures

Name	Time	Method
Distance lead to nerve	1 week	The exact distance (mm) will be assessed from the lead to the nerve

Secondary Outcome Measures

Name	Time	Method
Neuroforamen	1 week	The inserted neuroforamen will be assessed.
Sacral fascia	1 week	A perforation throw the sacral fascia will be noted.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria